BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9614385-2006-00046

    MDR report key: 746166 · Received August 9, 2006

    Report

    Report Number
    9614385-2006-00046
    Event Type
    Injury
    Date Received
    August 9, 2006
    Product Code
    FWM
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION: VISUAL INSPECTION IDENTIFIED A LARGE BREACH APPROX 200MM IN LENGTH WHICH FOLLOWS THE PERIPHERY OF THE DEVICE FROM THE 11 O'CLOCK POSITION TO THE 6 O'CLOCK POSITION (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRODUCT INSPECTION: PRESSURE TESTING COULD NOT BE COMPLETED DUE TO THE SIZE AND POSITION OF THE BREACH MICROSCOPIC EXAMINATION (X10) OF THE BREACH IDENTIFIED A CLEAR INITIATION POINT WHICH IS INDICATIVE OF MECHANICAL TRAUMA. THE PRODUCT MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS POST MFR. CONCLUSIONS: THE BREACH WAS NOT A MANUFACTURING FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FWM

    Patients

    Seq Age Sex Outcome Treatment
    1